Cleared Traditional

BIOCHRON FERTILITY INDICATOR (K852801) - FDA 510(k) Clearance

K852801 · Fertil-A-Chron, Inc. · Obstetrics & Gynecology device
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Sep 1985
Decision
80d
Days
-
Risk

K852801 is an FDA 510(k) clearance for the BIOCHRON FERTILITY INDICATOR. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Fertil-A-Chron, Inc. (Hauppauge, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fertil-A-Chron, Inc. devices

Submission Details

510(k) Number K852801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date September 19, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 160d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHD Device, Fertility Diagnostic, Proceptive
Device Class -